mFOLFOX6方案与SOX方案化疗治疗不可切除的胆囊癌肝转移的临床疗效及安全性比较

目的:比较mFOLFOX6方案（奥沙利铂+亚叶酸钙+5-氟尿嘧啶）与SOX方案（奥沙利铂+替吉奥）化疗治疗不可切除的胆囊癌肝转移的临床疗效及安全性。方法:将我院收治的208例不可切除的胆囊癌肝转移患者随机分为观察组及对照组，每组104例。对照组均给予mFOLFOX6方案进行化疗，观察组则均给予SOX方案进行化疗，两组患者均连续治疗4个疗程。治疗期间，观察两组患者毒副反应发生情况，主要观察指标包括肝毒性、神经毒性、心脏毒性、白细胞计数降低情况、胃肠道反应及血小板降低情况等。治疗后，观察两组患者临床疗效。治疗前后，对两组患者白蛋白（ALB）、总胆红素（TBIL）、天门冬氨酸氨基转移酶（AST）及谷丙转氨酶（ALT）等肝功能指标含量进行检测。治疗后，对两组患者进行为期2年的随访，观察两组患者1年生存率、2年生存率、无疾病进展生存时间（PFS）和总生存时间（OS）。结果:治疗后，观察组客观缓解率（ORR）及临床获益率（CBR）均明显高于对照组（P<0.05）。治疗期间，观察组肝毒性、神经毒性、心脏毒性、白细胞计数降低、胃肠道反应及血小板降低等毒副反应的发生率均明显低于对照组（P<0.05）。治疗后，观察组ALB、TBIL、AST及ALT等肝功能指标的改善程度均显著优于对照组（P<0.05）。治疗后，观察组1年生存率、2年生存率、PFS及OS均显著高于对照组（P<0.05）。结论:SOX方案化疗治疗胆囊癌肝转移患者的疗效优于mFOLFOX6方案，且安全性更佳。

Comparison on the efficacy and safety of mFOLFOX6 method and SOX method in the treatment of liver metastasis of gallbladder carcinoma

Objective:To compare the efficacy and safety of mFOLFOX6 method and SOX method in the treatment of liver metastasis of gallbladder carcinoma.Methods:208 patients with liver metastasis of gallbladder carcinoma in our hospital were selected as the participants and randomly divided observation group（104 cases) and control group（104 cases).The control group was treated by mFOLFOX6 method，while the observation group was treated by SOX method.During the treatment，toxicity effects in the two groups were observed，including liver toxicity，neurotoxicity，cardiac toxicity，decreased white blood cell count，gastrointestinal reaction and thrombocytopenia.After treatment，the curative effects were evaluated.Before and after treatment，the levels of liver function in the two groups were evaluated，mainly containing albumin（ALB)，total bilirubin（TBIL)，aspartate aminotransferase（AST) and alanine transaminase alt（ALT).After treatment，2 years-followed up in the two groups were observed，and 1-year survival rate，2-year survival rate，disease-free progression survival time（PFS) and total survival time（OS) were observed.Results:After treatment，the ORR and CBR in the observation group were significantly higher than the control group（P<0.05).During the treatment，the rates of liver toxicity，neurotoxicity，cardiac toxicity，decreased white blood cell count，gastrointestinal reaction and thrombocytopenia in the observation group were significantly lower than the control group（P<0.05).After treatment，the liver function index（ALB，TBIL，AST and ALT) were significantly promoted in the observation group than those of the control group（P<0.05）.After treatment，the 1-year survival rate，2-year survival rate，PFS and OS in the observation group were significantly higher than the control group（P<0.05).Conclusion:SOX method has a better effect and safety for therapy in the treatment of liver metastasis of gallbladder carcinoma than the mFOLFOX6 method.